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SODIUM SALICYLATE CONCENTRATE (sodium salicylate) solution
[Aurora Pharmaceutical LLC]


Category DEA Schedule Marketing Status
OTC ANIMAL DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

INDICATIONS

For use in the drinking water of poultry and swine as an aid in reducing pain, fever and inflammation.

ACTIVE INGREDIENT
Sodium Salicylate                   48.6% w/v

CALF LABEL CLAIM

Indications For Use, Calves

Supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g., anti-infective) therapy if necessary.

Contraindications, Calves

Do not use Sodium Salicylate in neonates or calves less than 2 weeks of age.

Dosage, Calves

40 mg Sodium Salicylate per kg body weight (4 ml per 100 lbs.) once daily, for 1–3 days. Administer orally in drinking water or milk (replacer).

Recommended withdrawal period for all food animals following use at "usual dosages": meat 24 hours.

DIRECTIONS FOR USE

For Analgesic and Antipyretic Use

Water Proportioner Use

Add 8 ounces (236 ml) of Sodium Salicylate 48.6% Concentrate to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 11.3 mg/lb (25 mg/kg) body weight daily.

Livestock Tank Use

Add 8 ounces (236 ml) of Sodium Salicylate 48.6% Concentrate to 128 gallons of drinking water. This will achieve a target dose of 11.3 mg/lb (25 mg/kg) body weight daily.

For Anti-Inflammatory/Anti-Prostaglandin Use
Water Proportioner Use: Add 16 ounces (473 ml) of Sodium Salicylate 48.6% Concentrate to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 22.7 mg/lb (50 mg/kg) body weight daily.
Livestock Tank Use: Add 16 ounces (473 ml) of Sodium Salicylate 48.6% Concentrate to 128 gallons of drinking water. This will achieve a target dose of 22.7 mg/lb (50 mg/kg) body weight daily.
Following Days
Water Proportioner Use: Add 10 ounces (296 ml) of Sodium Salicylate 48.6% Concentrate to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 13.6 mg/lb (30 mg/kg) body weight daily.
Livestock Tank Use: Add 10 ounces (296 ml) of Sodium Salicylate 48.6% Concentrate to 128 gallons of drinking water. This will achieve a target dose of 13.6 mg/lb (30 mg/kg) body weight daily.
Prepare fresh solutions daily. Repeat as necessary.

WARNING

Do not administer concentrated solution by direct oral administration — gastrointestinal irritation or overdose may occur. Do not use in piglets less than 4 weeks of age.

Store at controlled room temperature between 15°–30° C (59°–86° F).

Do not use in food producing animals less than 1 day prior to slaughter.

CAUTION

Keep container closed when not in use. Product may solidify at cold storage temperatures. Place container in room temperature storage, which will thaw the solution, or place in warm water. Gently invert container to ensure uniformity of product.

Gradual darkening will not affect product stability.

MANUFACTURED IN THE USA

Take Time image

REORDER NO: 21004

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1108 REV 02

PRINCIPAL DISPLAY PANEL - 3.79 Liters Bottle Label

NDC 51072-038-01

ORAL-PRO™

Sodium Salicylate
Concentrate 48.6% w/v

For Use in Livestock Only

Keep Out of Reach of Children

Net Contents:
1 Gallon (3.79 Liters)

aurora
PHARMACEUTICAL

PRINCIPAL DISPLAY PANEL - 3.79 Liters Bottle Label
SODIUM SALICYLATE  CONCENTRATE
sodium salicylate solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-038
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM SALICYLATE (SALICYLIC ACID) SODIUM SALICYLATE48.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water69.8 g  in 100 mL
Packaging
#Item CodePackage Description
1NDC:51072-038-013790 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/16/2011
Labeler - Aurora Pharmaceutical LLC (832848639)
Establishment
NameAddressID/FEIBusiness Operations
Aurora Pharmaceutical LLC832848639MANUFACTURE

Revised: 01/2013
Document Id: 9426dec1-9864-4dd8-bd34-ae44ca20696d
Set id: 2f31976b-cf71-4ae0-a153-0ee242430931
Version: 4
Effective Time: 20130110
 
Aurora Pharmaceutical LLC

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